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Completed

NCT Number: NCT03361514

Discontinuation of Antidepressant Medication in Primary Care.

To investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and Mindfulness-Based Cognitive Therapy (MBCT) in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.

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Key information

Conditions

Antidepressants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

About this study

Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing antidepressants appears to be challenging for both patients and general practitioners. Mindfulness-Based Cognitive Therapy (MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms and fear of relapse. The current study aims to investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.

Methods/Design This study involves a cluster-randomized controlled trial conducted in primary care patients with long-term use antidepressants with baseline and 6, 9 and 12 months follow-up assessments. Patients choosing to discontinue their medication will be offered a combination of supported protocolized discontinuation (SPD) and MBCT or SPD alone. Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Secondary outcome measures will be the severity of withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of life and medical and societal costs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having received prescriptions for antidepressants in primary care for at least the past nine months

Exclusion criteria

  • Current treatment by a psychiatrist
  • Current diagnosis of substance use disorder
  • Non-psychiatric indication for long-term antidepressant usage (i.e. neuropathic pain)
  • Having participated in a mindfulness training (> 3 sessions) within the last 5 years
  • Inability to perform the assessments due to cognitive or language difficulties
  • Younger than 18 years

Treatment and study plan

Supported Protocolized Discontinuation (SPD)

Behavioral

Patients who choose to discontinue their medication will make a personal tapering schedule with their GP based upon a discontinuation protocol with tapering suggestions. The protocol offers suggestions to taper within a maximum of 6 months describing all types of available dosages per antidepressant so individualized schedules can be constructed. In addition, they will be offered supportive meetings with the GP's mental health assistant. The assistant will receive basic information about discontinuation guidance, i.e. the information brochure, decision aid, discontinuation protocol and a short guideline how to organise consultations.

Mindfulness Based Cognitive Therapy (MBCT)

Behavioral

In addition to the SPD patients are offered Mindfulness Based Cognitive Therapy (MBCT) in homogeneous groups of patients willing to withdraw from their medication. MBCT will be offered according to the treatment protocol developed for recurrent depression, adaptated to the specific needs of patients discontinuing their antidepressant medication. The mindfulness courses will be provided by teachers qualifying the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders. All teachers will receive additional training in using the specific study protocol at the start of the project.

Primary outcomes

  1. Number of patients who fully discontinued their antidepressant medication after 6 months.

    Time frame: 6 months

    Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Use of medication will be measured with daily calendars. Patients daily fill out paper calendars describing their daily milligrams of their antidepressant use.

Secondary outcomes

  1. Structured Clinical Interview for DSM-IV-TR Disorders

    Time frame: baseline and 6, 9 and 12 months

    Diagnostic instrument to assess relapse of depressive episode

  2. Discontinuation-Emergent Signs and Symptoms

    Time frame: baseline and 6, 9 and 12 months

    Self-report measure for assessing signs and symptoms associated with discontinuation or interruption of SSRI treatment.

  3. Inventory of Depressive Symptomatology

    Time frame: baseline and 6, 9 and 12 months

    A clinican-administered interview assessing the severity of depressive symptoms

  4. State/Trait Anxiety Inventory

    Time frame: baseline and 6, 9 and 12 months

    Self-report measure for assessing both state and trait levels of anxiety

  5. Module Suicide Cognitions of the Mini International Neuropsychiatric Interview

    Time frame: baseline and 6, 9 and 12 months

    A clinican-administered interview assessing the suicidal cognitions and to specify suicidal risk

  6. Mental Health Continuum - short form

    Time frame: baseline and 6, 9 and 12 months

    Self-report questionnaire that assesses emotional, psychological and social well-being

  7. Five Facet Mindfulness Questionnaire

    Time frame: baseline and 6, 9 and 12 months

    Self-report measure assessing mindfulness skills

  8. Self-Compassion Scale

    Time frame: baseline and 6, 9 and 12 months

    Self-report measure consisting of 12 items addressing six components: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification

Other outcomes

  1. Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness

    Time frame: baseline and 6, 9 and 12 months

    Health service receipt self-report measure designed for economic evaluations in the Netherlands

  2. Euro-Quality of Life 5D-5L

    Time frame: baseline and 6, 9 and 12 months

    Short self-report instrument to assess quality adjusted life years

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Innovatiefonds Zorgverzekeraars
  • Pro Persona Mental Health Care Foundation

Registry information

Official study title

Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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